Many people require daily monitoring of their blood glucose levels. A number of available systems allow people to conveniently monitor their blood glucose levels. Such systems typically include a disposable test strip to which the user applies a blood sample, and a meter that determines the blood glucose level.
Among the various technologies available for measuring blood glucose levels, electrochemical technologies are desirable at least in part because small volumes of blood sample can be used. In electrochemical-based systems, the test strip typically includes electrodes and a sample chamber that contains chemical constituents, such as a glucose enzyme and an electron mediator. When the user applies a blood sample to the test strip, blood is drawn into the sample chamber, and chemical constituents react with the glucose present in the blood. In amperometric electrochemical systems, the instrument applies a voltage to the electrodes to cause a redox reaction. The meter initiates one or more current measurements and calculates the glucose level based on at least one of the current measurements.
There remains a continual need to develop accurate measurements of blood glucose levels, which can help maintain the long-term health of many users. Exemplary areas of development include enhanced reliability, ease-of-use, and robust tolerance of poor user technique in the design of meters and test strips. However, as sample sizes become smaller, the dimensions of the sample chamber and electrodes in the test strip must also become smaller. This, in turn, can render the test systems more sensitive to manufacturing process and component variations, environmental factors, user technique shortcomings, damage from handling, etc. Accordingly, there is a continuing need for reliable low-volume biosensor test-strips, and also for low cost, high manufacturing volume, efficient biosensor test strip manufacturing processes.
Several methods for manufacturing biosensors have been proposed. One such method is described in U.S. Pat. No. 6,875,327 to Mivazaki et al. Miyazaki et al. describe a biosensor manufacturing process whereby a conductive layer is formed on a support.
Electrodes are formed using a laser to form multiple “slits” in the conductive layer, electrically separating the working, counter and detecting electrodes. Following electrode formation, chemical reagents are selectively applied to the conductive layer.
Although the electrode design described by Miyazaki et al. can provide a functional biosensor, the manufacturing process can be improved. Specifically, the manufacturing process can be inefficient, time consuming, or unsuitable to form one or more biosensors described in the present disclosure.
The present disclosure is directed to a manufacturing method designed to overcome one or more of the limitations in the prior art.